Director, Quality Systems

This is a fully remote position, open to applicants in Germany.

📋 Description

• You will take on comprehensive disciplinary and functional accountability for the design and enhancement of the global Quality Management System (QMS).

• You will serve as the principal architect for an innovative, digital quality framework, ensuring that all GxP processes (GMP, GVP, GCP) comply with the highest regulatory standards.

• Strategic leadership: You will guide a global, cross-functional team, manage resource and budget planning, and serve as the single point of contact (SPOC) for escalations.

• QMS design & governance: You will be tasked with the creation, implementation, and ongoing optimization of a process-focused QMS across all GxP areas (e.g., deviation, CAPA, change control, management review).

• Digital quality infrastructure: You will ensure a compliant and future-ready system architecture, select eQMS solutions, and supervise the alignment of IT systems within the Science function.

• Data Integrity & CSV: You will be responsible for data integrity governance and computerized system validation (CSV) in strict adherence to global regulations.

• Stakeholder management: You will function as the primary liaison with regulatory authorities, contract manufacturers (CMOs), and suppliers, fostering cross-functional collaboration throughout the organization.

• Capability building: You will ensure organizational competence by developing and implementing focused training and qualification initiatives.

⛳️ Requirements

• A successfully completed degree (Master’s/PhD) in a scientific or pharmaceutical field, along with a robust GxP background.

• Over 10 years of pertinent professional experience in quality management, including at least a decade in disciplinary and functional leadership positions within complex, regulated GxP environments (GMP, GVP, GCP).

• Extensive expertise in QMS design, eQMS platforms, and data integrity governance.

• Proficient in managing science IT systems, CSV, and digital quality tools.

• Strong analytical abilities to identify systemic quality risks early and convert them into structured improvement initiatives.

• Confident in interactions with regulatory authorities and adept at managing external partners.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career advancement.

• Flexible working arrangements to promote work-life balance.